BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE MEDICAL OMNIBED, CARESTATION AND INCUBATOR

    MDR report key: 21333869 · Received February 6, 2025

    Report

    Report Number
    MW5165758
    Event Type
    Other
    Date Received
    February 6, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 3, 2025
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES - CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    FMZ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GE MEDICAL HAS POSSIBILITY OF REPLACING EAST/WEST DOORS ON OPPOSITE SIDES AND DOOR WILL FIT BUT NOT LATCH CORRECTLY. THERE HAVE BEEN MULTIPLE ALERTS ABOUT LABELING AND LATCHING BUT NO MENTION OF SWAPPING THE EAST/WEST DOORS INCORRECTLY RESULTING IN NOT BEING ABLE TO LATCH THEM. THIS HAS OCCURRED SEVERAL TIMES AT OUR HOSPITAL AND BIOMED INTERVENED TO SWAP DOOR TO CORRECT SIDES FOR PROPER LATCHING. THIS AFFECTS GE GIRAFFE OMNIBED INCUBATOR CARESTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785101 GE MEDICAL OMNIBED, CARESTATION AND INCUBATOR INCUBATOR, NEONATAL FMZ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES - CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown